A prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with docetaxel to placebo in combination with docetaxel in first line metastatic Castrate Resistant Prostate Cancer (mCRPC)

Trial Profile

A prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with docetaxel to placebo in combination with docetaxel in first line metastatic Castrate Resistant Prostate Cancer (mCRPC)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Jun 2018

At a glance

  • Drugs Masitinib (Primary) ; Docetaxel; Prednisone
  • Indications Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors AB Science
  • Most Recent Events

    • 19 Jun 2018 According to an AB Science media release, this study is expected to be completed in 2019.
    • 19 Jun 2018 According to an AB Science media release, based on results from pre-planned interim analysis, the IDMC has recommended the continuation of study in a pre-specified sub-population of patients that were identified based on a specific biological biomarker of disease aggressiveness, and estimated to account for about two-third of the eligible population.A total of 468 patients are to be enrolled in this sub-population, while enrolment of patients with an absence of this biomarker will be stopped.
    • 30 Apr 2018 According to an AB Science media release, Results of the interim analysis are expected in 2018.
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